Manager, Quality Management

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) ensures full integration of development and commercialization activities, from initiation of the clinical program for a compound through product positioning and global life cycle management, which will lead to globally consistent branding of our products.

 

 

Otsuka is seeking a Manager, Quality Management who will be involved in the day-to-day auditing functions of the department.  The incumbent will mentor the Quality Management personnel (including external QM contract auditors) to develop in the profession and to benefit OPDC.  The Manager, Quality Management (QM) is an experienced GXP quality assurance professional.

 

The Manager, Quality Management meets with multi-functional representatives and assures appropriate representation of the department on various OPDC initiatives.  The Manager, Quality Management presents QM concerns to QMRI Management, functional areas, and external OPDC customers as required.  The Manager oversees the activities of supplement staff members (mostly contract auditors) under contract with OPDC QM. This position works in conjunction with the Director and Associate Director to assure coordination of efforts within the department and to assure compliance throughout the drug development process at OPDC. 

 

The Manager, Quality Management provides guidance and shares expertise with Otsuka personnel in the interpretation of clinical development regulations and Good Clinical Practice (GCP) guidelines, Quality Assurance audit conduct and reporting, training of auditors, preparation for and management of regulatory inspections.

 

The specific duties assigned to the Manager, Quality Management include:Provides oversight and training of the Quality Management personnel in all aspects of the Quality Management function.Involved in the day-to-day auditing functions of the department and mentors the auditors both internal and external to develop in the profession and to benefit OPDC.Meets with multi-functional representatives and assures representation of the department on various OPDC initiatives.  This includes oversight of the QM Liaisons� roles and overall departmental goals and objectives.Presents QM concerns to OPDC Management, functional areas, and external OPDC customers as required.  This may include other Otsuka organizations.Works in conjunction with the Director and Associate Director to assure coordination of efforts within the department and with external contracted personnel to assure compliance throughout the drug development process at OPDC.Provides guidance and shares expertise with Otsuka personnel in the interpretation of clinical development regulations and Good Clinical Practice (GCP) Guidelines, Quality Management audit conduct and reporting, training of auditors, preparation for and management of regulatory inspections.

The successful candidate must meet the following minimum requirements:Bachelor's degree in a Life Science with 5 years auditing experience in worldwide clinical pharmaceutical development.  Project and Team/contractor supervisory experience of 2 years. Good working knowledge of Good Clinical Practice principles, FDA regulations regarding clinical development, ICH Efficacy Guidelines, auditing techniques and governmental regulatory inspection procedures.Must possess good oral and written communication skills.  Demonstrated skills to interact with regulatory inspectors, make presentations at investigator meetings, manage �for cause� audits and present findings in a tactful manner.Working proficiency with Microsoft Office applications.Ability to travel - 30%. 

We offer a competitive compensation and benefits package plus a positive work environment, which encourages personal growth and achievement.

For immediate consideration, qualified candidates should apply online at www.otsuka.com   Click on OPDC, Careers, then Employment Opportunities.  Enter 08-006 for keyword search.  Applicants may also submit resumes via email to humanresources@otsuka.com .  Due to the volume of resumes, only applicants considered for interviews will be contacted. 

 

Otsuka is an Equal Opportunity Employer.